Edwards EVOQUE Stabilizer 9850SZUS

GUDID 00690103219579

Edwards EVOQUE Stabilizer

Edwards Lifesciences LLC

Vascular catheter introduction set, nonimplantable
Primary Device ID00690103219579
NIH Device Record Key49ee47a0-5883-47f5-bc2d-3b211e104b03
Commercial Distribution StatusIn Commercial Distribution
Brand NameEdwards EVOQUE Stabilizer
Version Model Number9850SZUS
Catalog Number9850SZUS
Company DUNS134139174
Company NameEdwards Lifesciences LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry place

Device Identifiers

Device Issuing AgencyDevice ID
GS100690103219579 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QWACardiovascular Delivery Catheter System Positioning And Stabilization Device

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-07-17
Device Publish Date2025-07-09

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50690103205782 - ACUMEN IQ2025-07-18 ACUMEN IQ SENSOR 60'' / 152CM WITH FLUID METER WITH VAMP 5-PACK
00690103205817 - Acumen IQ Fluid Meter2025-07-18 Acumen IQ Fluid Meter
50690103205829 - ACUMEN IQ2025-07-18 Acumen IQ Fluid Meter
50690103205836 - Acumen IQ Sensor with Vamp with TruWave2025-07-18 ACUMEN IQ SENSOR 60'' / 152CM WITH FLUID METER WITH VAMP WITH TRUWAVE 5-PACK
00690103219494 - Edwards Reusable Rail Extension2025-07-17 Edwards Reusable Rail Extension
00690103219500 - Edwards Reusable Rail2025-07-17 Edwards Reusable Rail
00690103219562 - Edwards EVOQUE Loading System2025-07-17 Edwards EVOQUE Loading System

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